BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM

    MDR report key: 3093813 · Received May 6, 2013

    Report

    Report Number
    2024168-2013-02789
    Event Type
    Malfunction
    Date Received
    May 6, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    MGB
    PMA / PMN Number
    P960043
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS REPORTED TO BE DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SUTURE PLACEMENT WAS SUCCESSFUL USING 4 PROGLIDE DEVICES, 2 EACH IN THE LEFT AND RIGHT COMMON FEMORAL ARTERIES (CFA) (BI-LATERAL ACCESS) PRIOR TO AN ABDOMINAL AORTIC ANEURYSM INTERVENTIONAL PROCEDURE (AAA). TWO PROGLIDE DEVICES WERE SUCCESSFULLY PLACED IN THE LEFT CFA AND TWO PROGLIDE DEVICES WERE SUCCESSFULLY PLACED IN THE RIGHT CFA. THE ARTERIOTOMY WAS A 6F. DURING THE AAA PROCEDURE THE SHEATH WAS UPSIZED TO A 16F. REPORTEDLY AFTER THE AAA PROCEDURE, DURING THE ARTERIOTOMY CLOSURE, A SUTURE BREAK OCCURRED IN THE LEFT CFA WHILE PULLING AT THE SUTURES DURING KNOT ADVANCEMENT. THE SUTURES HAD NOT BEEN PULLED WITH MUCH FORCE ALTHOUGH THE SUTURE BROKE. THE BLEEDING DID NOT STOP SUFFICIENTLY SO THE SUTURES AND KNOT OF THE SECOND PROGLIDE DEVICE WERE ADVANCED TO THE ARTERY SURFACE AND BLEEDING STOPPED DIRECTLY AND HEMOSTASIS WAS ACHIEVED. HEMOSTASIS WAS SUCCESSFULLY ACHIEVED IN THE RIGHT CFA AFTER AAA PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT SEQUELAE. NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WAS REPORTED. THE PHYSICIAN IS REPORTED TO BE TRAINED IN THE USE OF THE PROGLIDE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197000 PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM SUTURE MEDIATED CLOSURE MGB AV-TEMECULA-CT 21127J1

    Patients

    Seq Age Sex Outcome Treatment
    1 SHEATH: 6F, 16FHEPARIN